Implementing Single Use Technologies in Sterile Vaccines Processing
This on-demand webinar presented by Charlotte Masy of GSK is a case study illustration of GSK’s strategic approach for sterility assurance.
One of the main challenges when considering single-use technologies in sterile vaccines manufacturing is to ensure the highest level of assurance of integrity and sterility.
This webinar presented by Charlotte Masy of GSK is a case study illustration of GSK’s strategic approach for sterility assurance.
- How a Quality by Design (QbD) approach has been applied to develop, design and qualify single-use systems for vaccine manufacturing
- How GSK manage sterility assurance concerns
- Assessing and mitigating risks to integrity of SUS in sterile applications
Technical Lifecycle Project Manager
Learn more about the Helium Integrity Test
Manage risk in your critical process with this high sensitivity, supplier integrity test for single-use systems, filling sets and mixer biocontainers
With the publication of the new chapters in USP <665> due in September join Ken Wong from Sanofi Pasteur, Desmond Hunt from United States Pharmacopeia and James Hathcock from Pall Biotech to get the latest updates.
Participants will learn:
- About the USP <665> standardized extraction solution protocol for manufacturing components and systems
- What is new and what has changed in USP <665> and <1665> (as of September 2020)
- The top issues influencing the alignment of the BioPhorum extractables protocol and USP <665>
- What level of data end-users can expect to see
- How to apply USP <665> data sets to support risk assessment and qualification of single-use systems
- The opportunities ahead for simplifying the adoption of single-use technologies
Don’t miss this free BioPharma Asia webinar to hear from subject matter experts serving on the USP and BPOG panels!